Huludao

Researchers are evaluating a combination therapy using BNT324, a B7-H3 antibody-drug conjugate, with BNT327, a bispecific antibody targeting PD-L1 and VEGF, in people with advanced or relapsed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). This two-part Phase Ib/II trial aims to find safe and effective dose levels and to assess the therapy's safety and clinical effects in different lung cancer groups, including treatment-nave and relapsed patients. The study uses a dose escalation design in Part 1 to establish two safe combination dose levels of BNT324 and BNT327. In Part 2, participants receive either the higher or lower recommended dose to determine the optimal dose for further study. Some groups are randomized to one of the two doses, while others receive the highest dose based on prior results. Both drugs are given by intravenous infusion during the treatment period. Participants undergo screening before starting treatment, followed by treatment and safety monitoring. Researchers track dose-limiting toxicities, adverse events, dose adjustments, and treatment discontinuations up to 90 days after treatment ends or until new anticancer therapy starts. They also evaluate objective response rates up to 87 months after the first dose. Ongoing survival follow-up is included to assess long-term outcomes and safety.

Researchers are investigating BNT3212, alone and combined with pumitamig (BNT327), in adults with advanced solid tumors who have no remaining standard treatment options. This first-in-human, open-label study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and early signs of effectiveness of these treatments. The study includes multiple phases to carefully explore dosing and potential benefits while monitoring participant safety. The study is divided into four parts: Part A tests increasing doses of BNT3212 alone, Part B expands these doses in specific tumor types, Part C tests dose escalation of BNT3212 combined with pumitamig, and Part D expands this combination in select patient groups. Treatments are given by intravenous infusion, with doses adjusted or expanded based on ongoing safety and efficacy data. This stepwise approach helps identify the recommended doses for future studies. Participants will be closely monitored throughout the study period, which may last up to around 31 months, including follow-up after the last dose. Researchers will track side effects, treatment interruptions, and responses to therapy. Assessments include imaging for tumor measurements, laboratory tests for organ function, immune response evaluations, and overall health status. Safety observations continue up to 90 days post-treatment to ensure participant well-being.

Researchers are evaluating a new compound called AZD8205 as a potential treatment for advanced or metastatic solid tumors, either alone or combined with other anti-cancer drugs. This Phase I/IIa multi-center, open-label study focuses on patients with advanced solid tumors including breast cancer, biliary tract cancer, ovarian cancer, endometrial cancer, and squamous non-small cell lung cancer. The study aims to understand the safety and effects of AZD8205 and its combinations in these patient populations. Participants may receive AZD8205 alone or combined with other agents such as rilvegostomig, a bispecific antibody targeting TIGIT and PD-1; saruparib, a PARP inhibitor; or AZD9574, another PARP inhibitor. Various combinations include AZD8205 with rilvegostomig, saruparib, both saruparib and rilvegostomig, or AZD9574 with or without rilvegostomig. The study uses dose escalation and expansion phases to assess these treatments. Treatment is given according to the assigned group, with dosing schedules and combinations tailored to evaluate safety and tolerability. During the study, participants will be closely monitored for safety including adverse events, serious adverse events, and dose-limiting toxicities. Laboratory tests, ECGs, and vital signs will be regularly checked from the time of informed consent through 30 days after the last dose, covering about one year in total. Researchers will also assess measurable disease response and overall health status. This comprehensive evaluation helps determine the potential of AZD8205 and its combinations as treatments for advanced solid tumors.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are evaluating the safety and effectiveness of Dato-DXd in patients with metastatic hormone receptor-positive, HER2 IHC 0 breast cancer that cannot be treated with chemotherapy. This Phase IIIb, multinational, open-label study focuses on patients whose cancer is locally advanced, inoperable, or metastatic and has not responded to endocrine therapy. About 100 participants will receive Dato-DXd at a dose of 6 mg/kg by intravenous infusion every 3 weeks, up to a maximum dose of 540 mg for those weighing 90 kg or more. Treatment will continue until the cancer progresses as assessed by imaging criteria (RECIST 1.1), unacceptable side effects occur, or the participant chooses to stop. Tumor biopsies and blood samples will be collected at baseline, during treatment, and at progression to study biomarkers. Tumor imaging will be done every 8 weeks for the first 48 weeks, then every 12 weeks thereafter until disease progression or new anticancer therapy starts. Participants will undergo regular evaluations including tumor imaging, laboratory tests, and biomarker analyses. The main outcome measured is progression-free survival, defined as the time from the first dose until cancer progression or death, assessed up to about 24 months. Safety and tolerability will be closely monitored throughout the study, which is expected to enroll over 18 months with data cutoff about 6 months after the last participant is dosed.

Researchers are evaluating the safety and effectiveness of Ifinatamab Deruxtecan (I-DXd) compared to treatment chosen by physicians for adults with relapsed extensive-stage small cell lung cancer (ES-SCLC). The study aims to find out if I-DXd can improve the objective response rate, meaning the proportion of patients whose cancer shrinks or disappears, and extend overall survival time compared to other treatments. Secondary goals include assessing safety, patient-reported outcomes, immune response to I-DXd, B7-H3 protein levels, and how the drug is processed in the body. Participants will receive either I-DXd at a dose of 12 mg/kg given intravenously on the first day of each 21-day treatment cycle or one of the physician's choice treatments including Topotecan, Amrubicin, or Lurbinectedin, administered according to local standards of care. The study is randomized and open-label, meaning treatments are assigned by chance and both patients and doctors know which treatment is given. During the study, participants will be closely monitored with tumor assessments to evaluate response and detect disease progression, safety evaluations, and quality of life questionnaires. The main outcomes measured are the objective response rate assessed by a blinded independent review and overall survival time, tracked for up to approximately five years after randomization. Researchers will also monitor for any adverse effects and collect health economics data to understand the broader impact of treatments.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are investigating the effectiveness and safety of rilvegostomig combined with gemcitabine plus cisplatin compared to durvalumab combined with gemcitabine plus cisplatin as first-line treatments for patients with advanced biliary tract cancer, including cholangiocarcinoma and gallbladder carcinoma. This is a global, phase III, randomized, open-label study focused on patients with unresectable locally advanced or metastatic disease who have not previously received treatment for advanced cancer. The study includes patients with known PD-L1 status and measurable tumors suitable for repeated evaluation. Participants will receive either rilvegostomig intravenously every three weeks along with gemcitabine and cisplatin given intravenously on days 1 and 8 of each 21-day cycle, or durvalumab intravenously every three weeks for up to eight cycles, followed by dosing every four weeks, along with the same chemotherapy regimen. Treatment is designed to evaluate first-line therapy effects, comparing these two immunotherapy combinations alongside standard chemotherapy. Throughout the study, patients will be closely monitored for overall survival, especially in those with PD-L1 expression of 1% or higher, over approximately four years. Assessments will include tumor measurements by CT or MRI using RECIST 1.1 criteria, performance status evaluations, and ongoing safety monitoring. The study aims to understand the impact of these treatments on survival and disease progression in advanced biliary tract cancer patients.

Researchers are evaluating the safety and effectiveness of a new combination treatment using Surovatamig (AZD0486), a fully human bispecific monoclonal IgG4 antibody, together with rituximab. This Phase III, global, randomized, open-label study focuses on participants with untreated follicular lymphoma (FL) to see if this combination offers added benefits compared to three standard chemoimmunotherapy regimens chosen by the investigator. The study has two parts: a safety run-in and the main Phase III comparison. The first part, the Safety Run-in, compares different dose levels of Surovatamig plus rituximab to find the recommended Phase III dose (RP3D). The second part, Phase III, involves three groups: two groups receiving different schedules of Surovatamig plus rituximab, and one group receiving one of three standard regimens (R-CVP with rituximab maintenance, R-CHOP with rituximab maintenance, or Bendamustine plus rituximab maintenance) as chosen by the investigator. Treatment schedules and doses are monitored closely through the study. Participants will be followed for up to 10 years to monitor the occurrence and severity of side effects, treatment discontinuations, dose changes, and overall safety. The main goal is to assess whether the new combination is superior to standard treatments. Regular evaluations include safety assessments and monitoring treatment effects over time, with attention to both short-term and long-term outcomes.